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Antimicrobial agent

Phase 2

Diabetic Foot Ulcers (DFUs) | Small molecule | Metabolic |Lakewood-Amedex Biotherapeutics Inc.|Last Updated: May 4, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Antimicrobial agent · 1 trial · 1 indication

Phase 2 1
NCT07565506Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFUDiabetic Foot Ulcers (DFUs)
NOT YET_RECRUITING24 Analytics
PHASE2NOT YET_RECRUITING
Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU
Diabetic Foot Ulcers (DFUs)
NCT0756550624
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Study Endpoints

Primary Endpoints

Primary Efficacy Outcome
From enrollment to the end of day 7 and at the end of treatment at day 14

The rate reduction in CFUs by ≥ 2 logs per pathogen, which is identified as typical and highly suspicious for being the cause of the infection compared to baseline.

Primary Safety Outcome
From enrollment to the end of study participation at 4 weeks

Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug as well as the number of SAEs per patient and cohort.

Secondary Endpoints

Treatment success by dose
From enrollment to the end of treatment at 2 weeks
Treatment failures by dose
From enrollment to the end of treatment at 2 weeks
Secondary safety outcomes
From enrollment to 7 days of treatment, end of treatment at 2 weeks, and end of study participation in the study at 4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
2.5mg doseEXPERIMENTALTwice daily application for 14 days
5mg doseEXPERIMENTALTwice daily application for 14 days
10mg doseEXPERIMENTALTwice daily application for 14 days

Interventions

NameTypeDescription
Antimicrobial agentDRUGTopical antimicrobial gel application twice a day for 2 weeks
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable. 3. Non-hospitalized ambulatory subjects diagnosed with diabetes melli...

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Frequently asked questions about Antimicrobial agent

What is Antimicrobial agent used for?

Antimicrobial agent is an investigational small molecule being developed for the treatment of Diabetic Foot Ulcers (DFUs). It is formulated as Nu-3 Gel and is currently in Phase 2 clinical development. The drug is being studied in patients with mild infected diabetic foot ulcers (iDFU).

Who makes Antimicrobial agent?

Antimicrobial agent is being developed by Lakewood-Amedex Biotherapeutics Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for the treatment of Diabetic Foot Ulcers.

What phase is Antimicrobial agent in?

Antimicrobial agent is currently in Phase 2 clinical development. A Phase 2a dose-finding study is planned to evaluate the drug in subjects with mild infected diabetic foot ulcers. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Antimicrobial agent in?

Antimicrobial agent is being studied in a Phase 2a dose-finding trial with the identifier NCT07565506. This randomized, double-blind, controlled study will enroll 24 participants aged 18 years and older with mild infected diabetic foot ulcers. The trial is not yet recruiting.

Is Antimicrobial agent the same as Nu-3 Gel?

Yes, Antimicrobial agent is the same as Nu-3 Gel. The Phase 2a clinical trial is titled 'Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFU', indicating that the drug is administered as a gel formulation for the treatment of diabetic foot ulcers.